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Cytokine

Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Led By Ann (Annie) Silk
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of follow-up, up to 3 years
Awards & highlights

Study Summary

This trialwill evaluate the safety and effectiveness of combining two treatments (IL-2 and pembrolizumab) to fight advanced melanoma.

Eligible Conditions
  • Melanoma
  • Melanoma of the Head and Neck
  • Skin Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four to six weeks later, up to three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and four to six weeks later, up to three years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response Rate as Assessed by Response (BORR) Evaluation Criteria in Solid Tumors Version 1.1, With the Modification That Progressive Disease Must be Confirmed on a Subsequent Scan
Secondary outcome measures
Complete Response Rate
Number of Adverse Effects (AE) as Evaluated by National Cancer Institute Common Terminology Criteria for AE's, Version 4.0
Overall Survival Estimated Using Kaplan-Meier Curves
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, aldesleukin)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks and aldesleukin IV every 8 hours for up to 14 doses at weeks 4, 7, 16, 19, 28, and 31 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,222 Total Patients Enrolled
11 Trials studying Melanoma
2,278 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,675 Previous Clinical Trials
40,926,967 Total Patients Enrolled
557 Trials studying Melanoma
193,180 Patients Enrolled for Melanoma
Ann (Annie) SilkPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
Adam Berger, MD 2017. "Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02748564.
~1 spots leftby May 2025
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